RecruitingAdvanced Solid Tumors
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
You may qualify if…
- ✓ 1. Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study.
- ✓ 2. Age \> 18.
- ✓ 3. ECOG performance status of 0-1.
- ✓ 4. Life expectancy of ≥ 3 months.
- ✓ 5. Subjects with pathologically diagnosed advanced relapsed or refractory solid tumors, either gastric and gastroesophageal junction (GEJ) cancer, or pancreatic cancer, who are intolerable to SoC, have progressed through all available treatment options, or for whom there is no efficacious treatment available. Subjects must have pathological classification (e.g., adenocarcinoma etc.) documented.
- ✓ 6. Positive expression of Claudin 18.2 (\>= 50% of cells with 2+ or 3+ expression, either from fresh or archival tissue) is required prior to enrollment and participation in this study. Positivity for Claudin 18.2 is defined as tumor cells showing partial or complete membrane staining. The percentage of tumor cells at four different staining intensities will be estimated: 0 (no staining), 1+ (weak), 2+ (moderate), and 3+ (strong). The sum of all 4 percentages should equal 100%. The H-score is determined according to the H-Score formula: \[1 x Percentage of tumor cells stained at 1+\] + \[2 x Percentage of tumor cells stained at 2+\] + \[3 x Percentage of tumor cells stained at 3+\] = H-Score (range 0 or 1-300). Actual figure of Claudin 18.2 expression tested by IHC should be documented. Subjects must have pathological classification (e.g., adenocarcinoma) documented.
- ✓ 7. Has at least one measurable lesion as defined by RECIST v1.1.
- ✓ 8. Has adequate organ and bone marrow function within 7 days prior to administration of study treatment defined below: with no blood transfusion or hematopoietic growth factor support within 2 weeks prior to screening): • Absolute neutrophil count (ANC) ≥1.5 × 109 /L • Platelet count (PLT) ≥ 100 × 109 /L • Hemoglobin (Hb) ≥ 90 g/L • TBIL ≤1.5 × ULN • ALT and AST ≤ 3 × ULN (≤ 5 × ULN for liver metastasis) • Creatinine clearance ≥ 60 mL/min/1.73 m2 based on Cockcroft-Gault equation (Appendix 5) • Activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5 × ULN. • Fridericia-corrected QT interval (QTcF) ≤ 450 msec. If ECG demonstrates QTc \> 450 msec at screening, an ECG re-examination is allowed, and subjects will be eligible if it demonstrates QTc ≤ 450 msec. • LVEF ≥ 50%.
You may not qualify if…
- ✕ 1. Plan to receive any other anti-tumor treatments during the treatment period of this study.
- ✕ 2. Subjects participated in a prior investigational study or received anticancer treatment, and have not recovered from side effects of such therapy.
- ✕ 3. Underwent major surgical operation within 4 weeks before the first dose of this IP.
- ✕ 4. Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within \< 5 half-lives of the drug before the first dose of the study.
- ✕ 5. Previously received total gastrectomy (only for subjects of the dose-escalation part.
- ✕ 6. Adverse events caused by previous anti-tumor treatments have not recovered to Grade ≤ 1 according to NCI-CTCAE 5.0 (except for alopecia; some tolerable chronic Grade 2 toxicities may also be excluded as judged by the investigator after consultation with the sponsor).
- ✕ 7. Known to be allergic to any component of SHR-A1904 product (antibody conjugated toxin, antibody), or allergic to humanized monoclonal antibody products.
- ✕ 8. Subjects with known brain metastases, unless the participant is \> 1 month from definitive therapy (surgery or radiotherapy), has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study intervention.
Where it's recruiting
Florida
Miami Beach · St. Petersburg
Louisiana
New Orleans
Ohio
Cleveland
Rhode Island
Providence
South Carolina
Greenville
Texas
Houston
Source: ClinicalTrials.gov · NCT05277168 · last updated 2026-05-22